Hybrid drape having a gel-coated perforated mesh

ABSTRACT

A system for treating a tissue site with negative-pressure is described. The system includes a manifold configured to be positioned adjacent to the tissue site and a drape configured to be positioned over the tissue site and the manifold to form a sealed space. The system also includes a negative-pressure source configured to provide negative-pressure to the sealed space. The drape includes a film layer, a layer of a bonding adhesive coupled to the film layer, and a mesh coupled to the layer of the bonding adhesive. The mesh includes a coating of a sealing adhesive and one or more bonding apertures. Methods of manufacturing the drape are also described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/619,714, filed Feb. 11, 2015, entitled “HYBRID DRAPE HAVING AGEL-COATED PERFORATED MESH,” which claims priority to and the benefit ofU.S. Provisional Patent Application No. 61/945,882, filed Feb. 28, 2014,entitled “HYBRID DRAPE HAVING A GEL-COATED PERFORATED MESH,” each ofwhich is hereby incorporated by reference for all purposes.

FIELD

The present disclosure relates generally to dressings for adhering to awound or tissue site, and more particularly, but without limitation, toa hybrid drape having a gel-coated perforated mesh.

BACKGROUND

Clinical studies and practice have shown that reducing pressure inproximity to a tissue site can augment and accelerate growth of newtissue at the tissue site. The applications of this phenomenon arenumerous, but it has proven particularly advantageous for treatingwounds. Regardless of the etiology of a wound, whether trauma, surgery,or another cause, proper care of the wound is important to the outcome.Treatment of wounds or other tissue with reduced pressure may becommonly referred to as “negative-pressure therapy,” but is also knownby other names, including “negative pressure wound therapy,”“reduced-pressure therapy,” “vacuum therapy,” and “vacuum assistedclosure,” for example. Negative-pressure therapy may provide a number ofbenefits, including migration of epithelial and subcutaneous tissues,improved blood flow, and micro-deformation of tissue at a wound site.Together, these benefits can increase development of granulation tissueand reduce healing times.

While the clinical benefits of negative-pressure therapy are widelyknown, the cost and complexity of negative-pressure therapy can be alimiting factor in its application, and the development and operation ofnegative-pressure systems, components, and processes continues topresent significant challenges to manufacturers, healthcare providers,and patients.

SUMMARY

According to an illustrative, non-limiting embodiment, a dressing fortreating a tissue site with negative pressure is described. The dressingmay include a tissue interface configured to be positioned adjacent tothe tissue site; and a sealing member configured to be positioned overthe tissue interface and the tissue site to form a sealed environment.The sealing member may include a film layer, a layer of a bondingadhesive coupled to the film layer, and a mesh coupled to the layer ofthe bonding adhesive. The mesh may have a coating of a sealing adhesiveand one or more bonding apertures.

According to another illustrative embodiment, a system for treating atissue site with negative-pressure is described. The system may includea manifold configured to be positioned adjacent to the tissue site and adrape configured to be positioned over the tissue site and the manifoldto form a sealed space. The system may also include a negative-pressuresource configured to provide negative-pressure to the sealed space. Thedrape may include a film layer, a layer of a bonding adhesive coupled tothe film layer, and a mesh coupled to the layer of the bonding adhesive.The mesh may have a coating of a sealing adhesive and one or morebonding apertures.

According to another illustrative embodiment, a method for manufacturinga drape for a negative-pressure system is described. A film layer may beprovided, and a layer of a bonding adhesive may be coupled to the filmlayer. A mesh may be formed and coated with a sealing adhesive. One ormore bonding apertures may be formed in the mesh, and the mesh may becoupled to the layer of the bonding adhesive.

Other aspects, features, and advantages of the illustrative embodimentswill become apparent with reference to the drawings and detaileddescription that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

Illustrative embodiments are described in detail below with reference tothe attached drawings, which are incorporated by reference herein, andwherein:

FIG. 1 is a schematic diagram of an illustrative embodiment of a systemfor treating a tissue site with negative pressure;

FIG. 2 is an exploded perspective view of a drape that may be used withsome embodiments of the systems of FIG. 1;

FIG. 3A is a plan view of a mesh that may be used with some embodimentsof the drape of FIG. 2;

FIG. 3B is a perspective view of a portion of the mesh of FIG. 3A;

FIG. 3C is a side elevation view of a portion of the mesh of FIG. 3A;

FIG. 4 is a sectional view illustrating additional details that may beassociated with some embodiments of the drape of FIG. 2 in a firststate; and

FIG. 5 is a sectional view of the portion of the drape of FIG. 4 in asecond state.

DETAILED DESCRIPTION

The following description of example embodiments provides informationthat enables a person skilled in the art to make and use the subjectmatter set forth in the appended claims, but may omit certain detailsalready well-known in the art. The following detailed description is,therefore, to be taken as illustrative and not limiting.

The example embodiments may also be described herein with reference tospatial relationships between various elements or to the spatialorientation of various elements depicted in the attached drawings. Ingeneral, such relationships or orientation assume a frame of referenceconsistent with or relative to a patient in a position to receivetreatment. However, as should be recognized by those skilled in the art,this frame of reference is merely a descriptive expedient rather than astrict prescription.

FIG. 1 is a sectional view of an example embodiment of anegative-pressure therapy system 100 illustrating details that may beassociated with some embodiments for treating a tissue site 102 withnegative pressure. As shown in the illustrative embodiment of FIG. 1,the negative-pressure therapy system 100 may include a dressing 104fluidly coupled to a negative-pressure source 106. In some embodiments,the negative-pressure source 106 may be fluidly coupled to the dressing104 by a conduit, such as a tube 112, and a connector, such as aconnector 114. The dressing 104 may generally include a drape, such as adrape 108, and a tissue interface, such as a manifold 110. The drape 108may have a film layer 124, a layer of a bonding adhesive 126, and a mesh128. The drape 108 may be attached to an epidermis 116.

In general, components of the negative-pressure therapy system 100 maybe coupled directly or indirectly to each other. For example, thenegative-pressure source 106 may be directly coupled to the connector114 and indirectly coupled to the manifold 110 through the connector114. Components may be fluidly coupled to each other to provide a pathfor transferring fluids (such as, liquid, gas, or both liquid and gas)between the components.

In some embodiments, components may be fluidly coupled with a tube, suchas the tube 112, for example. A “tube,” as used herein, broadly refersto a tube, pipe, hose, conduit, or other structure with one or morelumina adapted to convey fluids between two ends. Typically, a tube isan elongated, cylindrical structure with some flexibility, but thegeometry and rigidity may vary. In some embodiments, components mayadditionally or alternatively be coupled by virtue of physicalproximity, being integral to a single structure, or being formed fromthe same piece of material. Coupling may also include mechanical,thermal, electrical, or chemical coupling (such as a chemical bond) insome contexts.

In operation, a tissue interface, such as the manifold 110, may beplaced within, over, on, against, or otherwise adjacent to a tissuesite. For example, the manifold 110 may be placed against the tissuesite 102, and the drape 108 may be placed over the manifold 110 andsealed to tissue proximate to the tissue site 102. Tissue proximate to atissue site is often undamaged epidermis peripheral to the tissue site.Thus, the drape 108 can provide a sealed therapeutic environment 118proximate to the tissue site 102. The sealed therapeutic environment 118may be substantially isolated from the external environment, and thenegative-pressure source 106 can reduce the pressure in the sealedtherapeutic environment 118. Negative pressure applied uniformly througha tissue interface in the sealed therapeutic environment 118 can inducemacrostrain and microstrain in the tissue site 102, as well as removeexudates and other fluids from the tissue site. The removed exudates andother fluids can be collected in a container and disposed of properly.

The fluid mechanics of using a negative-pressure source to reducepressure in another component or location, such as within a sealedtherapeutic environment 118, can be mathematically complex. However, thebasic principles of fluid mechanics applicable to negative-pressuretherapy are generally well-known to those skilled in the art, and theprocess of reducing pressure may be described illustratively herein as“delivering,” “distributing,” or “generating” negative pressure, forexample.

In general, exudates and other fluids flow toward lower pressure along afluid path. This orientation is generally presumed for purposes ofdescribing various features and components of negative-pressure therapysystems herein. Thus, in the context of negative-pressure therapy, theterm “downstream” typically implies something in a fluid path relativelycloser to a negative-pressure source, and conversely, the term“upstream” implies something relatively further away from anegative-pressure source. Similarly, it may be convenient to describecertain features in terms of fluid “inlet” or “outlet” in such a frameof reference. However, a fluid path may also be reversed in someapplications, such as by substituting a positive-pressure source, andthis descriptive convention should not be construed as a limitingconvention.

The term “tissue site” in this context broadly refers to a wound ordefect located on or within tissue, including but not limited to, bonetissue, adipose tissue, muscle tissue, neural tissue, dermal tissue,vascular tissue, connective tissue, cartilage, tendons, or ligaments. Awound may include chronic, acute, traumatic, subacute, and dehiscedwounds, partial-thickness burns, ulcers (such as diabetic, pressure, orvenous insufficiency ulcers), flaps, and grafts, for example. The term“tissue site” may also refer to areas of tissue that are not necessarilywounded or defective, but are instead areas in which it may be desiredto add or promote the growth of additional tissue. For example, negativepressure may be used in certain tissue areas to grow additional tissuethat may be harvested and transplanted to another tissue location. In anillustrative embodiment, the tissue site 102 may be a wound that extendsthrough the epidermis 116, through a dermis 120, and into subcutaneoustissue 122.

“Negative pressure” generally refers to a pressure less than a localambient pressure, such as the ambient pressure in a local environmentexternal to a sealed therapeutic environment 118 provided by the drape108. In many cases, the local ambient pressure may also be theatmospheric pressure in a patient's vicinity. Alternatively, thepressure may be less than a hydrostatic pressure associated with tissueat the tissue site. Unless otherwise indicated, values of pressurestated herein are gauge pressures. Similarly, references to increases innegative pressure typically refer to a decrease in absolute pressure,while decreases in negative pressure typically refer to an increase inabsolute pressure.

A negative-pressure source, such as the negative-pressure source 106,may be a reservoir of air at a negative pressure, or may be a manual orelectrically-powered device that can reduce the pressure in a sealedvolume, such as a vacuum pump, a suction pump, a wall-suction portavailable at many healthcare facilities, or a micro-pump, for example. Anegative-pressure source may be housed within or used in conjunctionwith other components, such as sensors, processing units, alarmindicators, memory, databases, software, display devices, or operatorinterfaces that further facilitate negative-pressure therapy. While theamount and nature of negative pressure applied to a tissue site may varyaccording to therapeutic requirements, the pressure typically rangesbetween −5 millimeters of mercury (mm Hg) (−667 Pa) and −500 mm Hg(−66.7 kPa). Common therapeutic ranges are between −75 mm Hg (−9.9 kPa)and −300 mm Hg (−39.9 kPa).

A tissue interface, such as the manifold 110, can generally be adaptedto contact a tissue site or other layers of a dressing. A tissueinterface may be partially or fully in contact with a tissue site. If atissue site is a wound, for example, a tissue interface may partially orcompletely fill the wound, or may be placed over the wound. A tissueinterface may take many forms, and may be many sizes, shapes, orthicknesses depending on a variety of factors, such as the type oftreatment being implemented or the nature and size of a tissue site. Forexample, the size and shape of a tissue interface may be adapted to thecontours of deep and irregular shaped tissue sites.

In some embodiments, a tissue interface may be a manifold, such as themanifold 110. A “manifold” in this context generally includes anysubstance or structure providing a plurality of pathways adapted tocollect or distribute fluid across a tissue site under negativepressure. For example, a manifold may be adapted to receive negativepressure from a source and distribute the negative pressure throughmultiple apertures across a tissue site, which may have the effect ofcollecting fluid from across a tissue site and drawing the fluid towardthe source. In some embodiments, the fluid path may be reversed or asecondary fluid path may be provided to facilitate delivering fluidacross a tissue site.

In some illustrative embodiments, the pathways of a manifold may bechannels interconnected to improve distribution or collection of fluidsacross a tissue site. For example, cellular foam, open-cell foam,reticulated foam, porous tissue collections, and other porous materialsuch as gauze or felted mat generally include pores, edges, and/or wallsadapted to form interconnected fluid pathways. Liquids, gels, and otherfoams may also include or be cured to include apertures and flowchannels. In some illustrative embodiments, a manifold may be a porousfoam material having interconnected cells or pores adapted to uniformly(or quasi-uniformly) distribute negative pressure to a tissue site. Thefoam material may be either hydrophobic or hydrophilic. In onenon-limiting example, a manifold may be an open-cell, reticulatedpolyurethane foam such as GranuFoam® dressing available from KineticConcepts, Inc. of San Antonio, Tex.

In some embodiments, such as embodiments in which the manifold 110 maybe made from a hydrophilic material, the manifold 110 may also wickfluid away from a tissue site while continuing to distribute negativepressure to the tissue site. The wicking properties of the manifold 110may draw fluid away from a tissue site by capillary flow or otherwicking mechanisms. An example of a hydrophilic foam is a polyvinylalcohol, open-cell foam such as V.A.C. WhiteFoam® dressing availablefrom Kinetic Concepts, Inc. of San Antonio, Tex. Other hydrophilic foamsmay include those made from polyether. Other foams that may exhibithydrophilic characteristics include hydrophobic foams that have beentreated or coated to provide hydrophilicity.

A tissue interface may further promote granulation at a tissue site ifpressure within the sealed therapeutic environment 118 is reduced. Forexample, any or all of the surfaces of the manifold 110 may have anuneven, coarse, or jagged profile that can induce microstrains andstresses at a tissue site if negative pressure is applied through themanifold 110.

In some example embodiments, a tissue interface may be constructed frombioresorbable materials. Suitable bioresorbable materials may include,without limitation, a polymeric blend of polylactic acid (PLA) andpolyglycolic acid (PGA). The polymeric blend may also include withoutlimitation polycarbonates, polyfumarates, and capralactones. The tissueinterface may further serve as a scaffold for new cell-growth, or ascaffold material may be used in conjunction with the tissue interfaceto promote cell-growth. In general, a scaffold material may be abiocompatible or biodegradable substance or structure used to enhance orpromote the growth of cells or formation of tissue, such as athree-dimensional porous structure that provides a template for cellgrowth. Illustrative examples of scaffold materials include calciumphosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, orprocessed allograft materials.

In some embodiments, the drape 108 may provide a bacterial barrier andprotection from physical trauma. The drape 108 may also be constructedfrom a material that can reduce evaporative losses and provide a fluidseal between two components or two environments, such as between atherapeutic environment and a local external environment. The drape 108may be, for example, an elastomeric film or membrane that can provide aseal adequate to maintain a negative pressure at a tissue site for agiven negative-pressure source. In some example embodiments, the drape108 may be a polymer drape, such as a polyurethane film, that ispermeable to water vapor but impermeable to liquid. Such drapestypically have a thickness in the range of about 25 microns to about 50microns. For permeable materials, the permeability generally should below enough that a desired negative pressure may be maintained.

An attachment device may be used to attach the drape 108 to anattachment surface, such as undamaged epidermis, a gasket, or anothercover. The attachment device may take many forms. For example, anattachment device may be a medically-acceptable, pressure-sensitiveadhesive that extends about a periphery, a portion, or an entire sealingmember. In some embodiments, for example, some or all of the drape 108may be coated with an acrylic adhesive having a coating weight betweenabout 25 grams per square meter (gsm) to about 65 gsm. Thickeradhesives, or combinations of adhesives, may be applied in someembodiments to improve the seal and reduce leaks. Other exampleembodiments of an attachment device may include a double-sided tape,paste, hydrocolloid, hydrogel, silicone gel, or organogel.

A “container” broadly includes a canister, pouch, bottle, vial, or otherfluid collection apparatus. A container, for example, can be used tomanage exudates and other fluids withdrawn from a tissue site. In manyenvironments, a rigid container may be preferred or required forcollecting, storing, and disposing of fluids. In other environments,fluids may be properly disposed of without rigid container storage, anda re-usable container could reduce waste and costs associated withnegative-pressure therapy. In some embodiments, a container may be acomponent of a negative-pressure source, such as the negative-pressuresource 106.

A “connector,” such as the connector 114, may be used to fluidly couplea tube to a sealed therapeutic environment. The negative pressuredeveloped by a negative-pressure source may be delivered through a tubeto a connector. In one illustrative embodiment, a connector may be aT.R.A.C.® Pad or Sensa T.R.A.C.® Pad available from Kinetic Concepts,Inc. of San Antonio, Tex. In one exemplary embodiment, the connector 114may allow the negative pressure generated by the negative-pressuresource 106 to be delivered to the sealed therapeutic environment 118. Inother exemplary embodiments, a connector may also be a tube insertedthrough a drape.

Negative-pressure therapy is increasingly being performed with smallerdevices that use battery power rather than a connection to an electricaloutlet. Use of battery power decreases the total power supply availableto a device. As a result, power drains that would be considerednegligible in a device powered through an electrical outlet connectionmay significantly reduce the performance of a battery-powered device.Power drains may be caused by low-level dressing leaks, for example,which can drain power by repeatedly triggering operation of the anegative-pressure source to maintain a therapeutic negative pressure atthe tissue site. Power drains can shorten the useful life of a device bydraining the device battery faster, requiring more frequent disposal ofthe device, recharging of the battery, or battery replacement. Leakdetection techniques may help to identify some leaks that may be sealedby the user; however, low-level leaks can challenge the most sensitiveleak detection systems and may often go undetected.

Low-level dressing leaks may occur between a drape and epidermissurrounding a tissue site if the drape fails to completely seal to theepidermis. Generally, a drape suitable for covering a tissue site fornegative-pressure therapy may comprise a film having a thickness betweenabout 25 microns and about 50 microns that is water-vapor permeable andformed of a polymer. The film, often formed of polyurethane, may becoated with an adhesive having a coating weight between about 25 gsm andabout 65 gsm. The adhesive may often be acrylic-based and pressuresensitive. A standard acrylic adhesive may have a bond strength betweenabout 1.8 Newton/centimeter (N/cm) and about 3.8 N/cm on stainless steelsubstrate at 23° C. at 50% relative humidity based on the AmericanSociety for Testing and Materials (“ASTM”) standard ASTM D3330. Apressure-sensitive adhesive increases in bond strength when pressedagainst the surface to which the adhesive is being bonded. In someapplications, a pressure-sensitive adhesive may undergo a physicalchange when compressed against a surface. In other applications, apressure-sensitive adhesive may flow into crevices of a surface whencompressed, increasing the bond strength without undergoing a physicalchange. A drape using a standard acrylic adhesive as described above isgenerally suitable for a dressing where a negative-pressure sourcepowered by a continuous power supply is available to compensate for adressing leak.

Some drapes may use a bonding adhesive instead of the standard acrylicadhesive. A bonding adhesive may be an adhesive having a bond strengththat is greater than the bond strength of a standard acrylic adhesive.In some embodiments, a bonding adhesive may be a type of acrylicadhesive. A bonding adhesive may be better for sealing, but theincreased bond strength may cause significantly more discomfort if thedrape is removed. In addition, removing a drape having a bondingadhesive may cause significant damage to delicate or damaged skin.

A drape that has a sealing adhesive can fill gaps between the drape andthe epidermis to limit leaks and can be easy to remove with lowdiscomfort to the patient. Generally, a sealing adhesive may have alower bond strength than a standard acrylic adhesive and a bondingadhesive. Generally, a sealing adhesive may flow into gaps and crevicesmore readily than a standard acrylic adhesive or a bonding adhesive.Various sealing, gap-filling adhesives, such as silicone, hydrocolloids,and hydrogels, have been used but each can have drawbacks. For example,hydrogel adhesives are usually low tack and prone to swelling, creep,and mobility when used with fluid systems. Available hydrogels andhydrocolloids may not adhere well and may move when anchored. In anotherexample, silicone adhesives can fill gaps and seal, but are notbreathable and may lose mechanical bonding strength as the siliconeadhesives interact with moisture during use. To counter these problems,silicone adhesives may require additional materials to secure thesilicone adhesive to a patient. For example, a low-leak drape may beformed from two adhesive layers: a thick sealing adhesive, perhaps inthe shape of a gasket or ring, and a thinner bonding adhesive layer usedto keep the sealing adhesive in place. Low-leak drapes constructed inthis way can be more complex than a drape using a single adhesive,increasing the complexity of manipulation and operation.

A hybrid drape having a thick sealing layer that is perforated andlaminated over an adhesive-coated film can overcome many of thesechallenges. For example, a hybrid drape may include a film layer havinga bonding adhesive applied directly to the film layer, and a sealingadhesive applied directly to the bonding adhesive. The sealing adhesivecan be perforated to expose the bonding adhesive. When the drape isapplied to a patient, the bonding adhesive can be pushed through theperforations of the sealing adhesive to secure the sealing adhesive tothe patient. This laminated configuration may provide the benefits ofthe sealing adhesive and the bonding adhesive over the entire drapearea. For example, the laminated configuration may be conformable and ofsufficient strength to ensure an initial seal, can inhibit thedevelopment of typical low-level leaks, and can mechanically affix to anepidermis without secondary processes. The laminated configuration mayalso minimize application care by a user and can be removable withminimal trauma to a patient.

However, construction of a laminated configuration can requireadditional assembly steps and can increase an amount of materials thatmay be needed for drape construction, which can also significantlyincrease costs. In addition, as two layers of adhesive are applied tothe film layer, the total thickness of the drape can significantlyincrease, reducing breathability of the drape. Still further, as twofull layers of adhesive are applied, significantly more adhesivematerial is needed to construct the drape.

Other hybrid drapes may register a bonding adhesive and a sealingadhesive. These hybrid drapes apply both a bonding adhesive and asealing adhesive directly to a film layer. The bonding adhesive and thesealing adhesive may each cover different portions of a film layer toreduce the overall thickness of a hybrid drape and decrease the amountof adhesive needed to construct the hybrid drape. However, thecomplexity of the manufacturing process may also increase costs relativeto other drapes. While using less adhesive than the laminated hybriddrapes, registered hybrid drapes may still use more adhesive inconstruction than standard drapes.

Some hybrid drapes may use a gel coated mesh having mesh apertures witha diameter between about 5 millimeters (mm) and about 15 mm. However, agel-coated mesh having apertures of this size may be unable to form aseal with a tissue site. The sealing properties of the gel-coated meshmay be improved by increasing an average diameter of the fibers used toform the mesh; however, the increased diameter of the fibers may alsoincrease a prominence of a mesh where two fibers intersect. A prominencemay be a relative height of a feature compared to surrounding features.If two fibers intersect so that a first fiber overlaps a second fiber, aprominence may be a distance between a top of a first fiber and the topof the second fiber. Generally, the prominence at an intersection of twofibers may be the diameter of the largest of the two intersectingfibers. Consequently, if the diameters of the fibers are increased toincrease the sealing properties of a gel-coated mesh, the raisedcontours associated with fiber cross-over may create leaks that aredifficult to seal.

As disclosed herein, the negative-pressure therapy system 100 canovercome these challenges and others by providing a substantially flatmesh coated with a sealing adhesive. In some embodiments, for example,the drape 108 may comprise a layer of a bonding adhesive coupled to afilm layer, and a mesh layer coupled to the layer of bonding adhesive.The mesh layer may be a mesh formed of small diameter fibers and can beperforated to form bonding apertures. The mesh may be coated with asealing adhesive.

FIG. 2 is an exploded perspective view, illustrating details that may beassociated with some embodiments of the drape 108. The film layer 124may be liquid-impermeable and vapor-permeable, allowing vapor to egressand inhibiting liquid from exiting. The film layer 124 may be a flexiblefilm that is breathable and may have a high moisture-vapor transfer rate(MVTR). For example, in some embodiments, the MVTR may be greater thanor equal to about 300 g/m²/24 hours. The film layer 124 may be formedfrom a range of medically approved films that typically range inthickness from about 15 microns (μm) to about 50 microns (μm). In otherembodiments, a drape having a low MVTR or that allows no vapor transfermay be used. The film layer 124 can also function as a barrier toliquids and microorganisms.

The film layer 124 may be formed from numerous materials, such as one ormore of the following: hydrophilic polyurethane (PU), cellulosics,hydrophilic polyamides, polyvinyl alcohol, polyvinyl pyrrolidone,hydrophilic acrylics, hydrophilic silicone elastomers, and copolymers ofthese. In an illustrative embodiment, the film layer 124 may be formedfrom a breathable cast matt polyurethane film sold by Expopack AdvancedCoatings of Wrexham, United Kingdom, under the name INSPIRE 2301. Theillustrative film may have an MVTR (inverted cup technique) of 14400g/m²/24 hours and may be approximately 30 microns thick.

The bonding adhesive 126 may be coupled directly to the film layer 124.The bonding adhesive 126 may be a medically-acceptable,pressure-sensitive adhesive. For example, the bonding adhesive 126 maybe formed from an acrylic adhesive, rubber adhesive, high-tack siliconeadhesive, polyurethane, or other substance. In some illustrativeembodiments, the bonding adhesive 126 may be formed from an acrylicadhesive with a coating weight of about 15 gsm to about 70 gsm. Thebonding adhesive 126 may also be a high-bond strength acrylic adhesive,patterrubber adhesive, high-tack silicone adhesive, or polyurethane, forexample. In some embodiments, the bonding adhesive 126 may have a peeladhesion or resistance to being peeled from a stainless steel materialbetween about 6N/25 mm to about 10N/25 mm on stainless steel substrateat 23° C. at 50% relative humidity based on the ASTM D3330.

The bonding adhesive 126 may be a continuous layer of material or may bea layer with apertures (not shown). The apertures may be formed afterapplication of the bonding adhesive 126 or may be formed by coating thebonding adhesive 126 in patterns on a carrier layer. The apertures maybe sized to help control the resultant tackiness of the bonding adhesive126. The apertures may also be sized to enhance the MVTR of the drape108. The bonding adhesive 126 may couple the film layer 124 to the mesh128.

In some embodiments, the mesh 128 may be a polymeric mesh, such asMepitel® produced by Molnlycke Health Care, Adaptic® produced bySystagenix, and Noveface produced by Zodiac Aerospace Group. In someembodiments, the mesh 128 may be substantially flat. For example, themesh 128 may have a thickness 129, and individual portions of the mesh128 may have a minimal tolerance from the thickness 129. In someembodiments, the thickness 129 of the mesh 128 may be about 1 mm, andthe tolerance of the thickness 129 may be less than about 2 mm. Inanother exemplary embodiment, a tolerance of the thickness 129 of themesh 128 may be less than about 1 mm. In other embodiments, a toleranceof the thickness 129 of the mesh 128 may be less than about 0.5 mm. Insome embodiments, the mesh 128 may be formed with bonding apertures 134.The bonding apertures 134 may be numerous shapes, for example, circles,squares, stars, ovals, polygons, slits, complex curves, rectilinearshapes, triangles, or other shapes.

FIG. 3A is a plan view, illustrating details that may be associate withsome embodiments of the mesh 128. Generally, a mesh may include astructure of connected strands of metal, fiber, or other flexible orductile material having openings between the strands. In someembodiments, a mesh may have evenly spaced openings between adjacentstrands. In some embodiments, the mesh 128 may have a plurality offibers 136. In some embodiments, the fibers 136 may be formed from amonofilament, a plurality of twisted monofilaments, a plurality offilaments, or a plurality of staple fibers. A filament may be a fiberthat is formed in a continuous or near-continuous length. A monofilamentmay be a single filament. In some embodiments, a monofilament may bemade from a single synthetic fiber of plastic, for example.Monofilaments may have a tensile strength related to a diameter of themonofilament and the type of material from which the monofilament isformed. A staple fiber may be a fiber of a selected standardized length,and the staple fiber may be formed of a suitable composition for usedwith a medical device. Each of the fibers 136 may have a diameter 127.In some embodiments, the diameter 127 may be no greater than about 1 mm.The fibers 136 may be formed from a range of materials including, butnot limited to, silicone, cellulose acetate, and other similarmaterials.

In some embodiments, antimicrobial agents may be added to the mesh 128.In other embodiments, the fibers 136 may have antimicrobial properties.For example, in some embodiments, silver ions may be added to the fibers136. In still other embodiments, the fibers 136 may be formed fromelastomers to permit easier coverage of complex contours.

The plurality of fibers 136 may be woven, knitted, knotted, linked orotherwise connected to form a regular pattern of mesh apertures. In someembodiments, each of the plurality of fibers 136 may be separated fromadjacent fibers 136 to form mesh apertures 139. In some embodiments, thefibers 136 may be separated a distance 138 from adjacent fibers, whichmay be between about 0.5 mm and about 4 mm. In some embodiments, each ofthe fibers 136 may be separated from adjacent fibers in a seconddirection by a distance 140. In some embodiments, the distance 140 maybe between about 0.5 mm and about 4 mm. In some embodiments, the firstdirection of the distance 138 and the second direction of the distance140 may be perpendicular. In some embodiments, the distance 138 and thedistance 140 may be the same. In other embodiments, the first directionof the distance 138 and the second direction of the distance 140 may beother angles, and the distance 138 and the distance 140 may not be thesame.

In some embodiments, the mesh apertures 139 may have an averageeffective diameter of about 1 mm. An effective diameter of anon-circular area may be a diameter of a circular area having the samesurface area as the non-circular area. For example, the surface area ofa mesh aperture 139 where the distance 138 is 0.5 mm and the distance140 is 0.5 mm may be 0.25 mm². The diameter of a circular area having a0.25 mm² surface area is about 0.56 mm; consequently, the effectivediameter of the exemplary mesh aperture 139 is about 0.56 mm. Similarly,if the distance 138 is about 4 mm and the distance 140 is about 4 mm,the effective diameter of the mesh aperture 139 may be about 4.51 mm.

In some embodiments, the mesh 128 may include the bonding apertures 134.The bonding apertures 134 may have a uniform pattern or may be randomlydistributed on the mesh 128. The bonding apertures 134 may be formedthrough one or more fibers 136. In some embodiments, the bondingapertures 134 may extend into the mesh apertures 139. Each bondingaperture 134 of the plurality of bonding apertures 134 may have aneffective diameter. The average effective diameter of each bondingaperture 134 may be in the range of about 5 mm to about 15 mm.

In some embodiments, the mesh 128 may be coated with a gel, such as asealing adhesive 144. In some embodiments, the sealing adhesive 144 mayhave a coating weight of about 100 gsm to about 500 gsm. In otherembodiments, the sealing adhesive 144 may have a coating weight greaterthan about 200 gsm. The coating of the mesh 128 with the sealingadhesive 144 may fill in a portion of each mesh aperture 139. In someembodiments, the mesh apertures 139 may remain at least partially openafter the coating of the mesh 128 with the sealing adhesive 144.

A sealing adhesive may be a soft material that provides a good seal withthe tissue site 102. A sealing adhesive may be formed of a silicone gel(or soft silicone), hydrocolloid, hydrogel, polyurethane gel, polyolefingel, hydrogenated styrenic copolymer gels, or foamed gels withcompositions as listed, or soft closed cell foams (polyurethanes,polyolefins) coated with an adhesive (for example, 30 gsm-70 gsmacrylic), polyurethane, polyolefin, or hydrogenated styrenic copolymers.In some embodiments, a sealing adhesive may have a stiffness betweenabout 5 Shore OO and about 80 Shore OO. A sealing adhesive may behydrophobic or hydrophilic. A sealing adhesive may be an adhesive havinga low to medium tackiness, for example, a silicone polymer,polyurethane, or an additional acrylic adhesive. In some embodiments, asealing adhesive may a bond strength between about 0.5N/25 mm and about1.5N/25 mm on a stainless steel substrate at 23° C. at 50% relativehumidity based on ASTM D3330. A sealing adhesive may have a tackinesssuch that the sealing adhesive may achieve the bond strength above aftera contact time of less than 60 seconds. Tackiness may be considered abond strength of an adhesive after a very low contact time between theadhesive and a substrate. In an illustrative embodiment, a sealingadhesive may have a tackiness that may be about 30% to about 50% of thetackiness of a bonding adhesive.

In some embodiments, the bonding apertures 134 may be formed prior tocoating of the mesh 128 with the sealing adhesive 144. In otherembodiments, the bonding apertures 134 may be formed in the mesh 128following coating of the mesh 128 with the sealing adhesive 144.

In some embodiments, the fibers 136 of the mesh 128 may form a pluralityof intersections 142. In some embodiments, an intersection 142 may be alocation of the mesh 128 where at least two fibers 136 overlap,cross-over, or meet, for example.

FIG. 3B is a perspective view, illustrating additional details that maybe associated with some embodiments of the mesh 128 of FIG. 3A. In someembodiments, the mesh 128 may be formed so that at each intersection142, the intersecting fibers 136 may be fused so that the intersection142 is planar. In some embodiments, the mesh 128 may be molded,extruded, or expanded to form the mesh 128. In embodiments where themesh 128 is molded, extruded, or expanded, the fibers 136 at anintersection 142 may be fused or joined so that a prominence at theintersection 142 is less than about 1 mm. In some embodiments, theprominence at an intersection 142 may be about 0 mm. In someembodiments, a substantially flat mesh may have a thickness at theintersections 142 that may be substantially the same as a thickness ofthe mesh 128 surrounding the intersections 142.

FIG. 3C is a side elevation view, illustrating additional details thatmay be associated with some embodiments of the mesh 128. In someembodiments, the mesh 128 may be formed by weaving or knitting thefibers 136. If the fibers 136 are woven or knitted, the intersections142 may have a prominence 141. In some embodiments, the prominence 141of the fibers 136 at the intersections 142 may be equal to the diameter127 of the fibers 136. In some embodiments, the prominence 141 may bereduced by compressing the mesh 128 following weaving or knitting thefibers 136. The prominences 141 of the fibers 136 may also be reduced bypassing the mesh 128 through a calender, which may apply pressure to themesh 128 to smooth out the mesh 128. In some embodiments, the prominence141 may be less than about 1 mm.

FIG. 4 is a sectional view, illustrating additional details that may beassociated with some embodiments of the drape 108. In the assembledstate, the bonding adhesive 126 may be coupled to the film layer 124,and the mesh 128 may be coupled to the bonding adhesive 126. If the mesh128 is placed proximate to or in contact with the epidermis 116, thesealing adhesive 144 coating the mesh 128 may form sealing couplings 146with the epidermis 116. In some embodiments, the diameter 127 of thefibers 136, the thickness of the sealing adhesive 144, and the bondingapertures 134 may create a gap between the bonding adhesive 126 and theepidermis 116.

FIG. 5 is a sectional view, illustrating additional details that may beassociated with some embodiments of the drape 108 of FIG. 4 in a secondposition. If the drape 108 is in a desired location, pressure may beapplied to the film layer 124. The pressure may cause the bondingadhesive 126 to be pressed at least partially into contact with theepidermis 116 to form bonding couplings 150. The bonding couplings 150may provide secure, releasable mechanical fixation to the epidermis 116.The sealing couplings 146 between the sealing adhesive 144 and theepidermis 116 may be sufficient to seal the film layer 124 to theepidermis 116. The sealing couplings 146 may not be as mechanicallystrong as the bonding couplings 150 between the bonding adhesive 126 andthe epidermis 116. The bonding couplings 150 may also anchor the drape108 to the epidermis 116, inhibiting migration of the drape 108 and thesealing adhesive 144.

The average effective diameter of the bonding apertures 134 of thesealing adhesive 144 may be varied as one control of the tackiness oradhesion strength of the drape 108. In this regard, there may be aninterplay between three main variables for each embodiment: the diameter127 of the fibers 136, the average effective diameter of the pluralityof bonding apertures 134, and the tackiness of the bonding adhesive 126.The more bonding adhesive 126 that extends through the bonding apertures134, the stronger the bonding coupling 150. The smaller the diameter 127of the fibers 136, the more the bonding adhesive 126 generally extendsthrough the bonding apertures 134 and the greater the bonding coupling150. As an example of the interplay, if a very tacky bonding adhesive126 is used and the diameter 127 of the fibers 136 of the mesh 128 issmall, the average effective diameter of the plurality of bondingapertures 134 may be relatively smaller to maintain a same adhesionstrength of the drape 108.

In other embodiments, the mesh 128 may be formed from a perforated filmwhich is then coated with the sealing adhesive 144 and laminated to thefilm layer 124 or the bonding adhesive 126. In other embodiments, themesh 128 may be coated with the bonding adhesive 126 and thenpattern-coated with the sealing adhesive 144. The mesh 128 may then belaminated directly to the film layer 124. The bonding adhesive 126 maybe exposed through the areas of the mesh 128 that were notpattern-coated with the sealing adhesive 144.

In some embodiments, the adhesives may be mixed with blowing orexpanding agents, for example organic and inorganic low temperatureboiling point liquids. The blowing or expanding agents allow for theadhesives to expand under the application of heat or light to increasethe thickness of the adhesive following deposition by one of the abovedescribed processes. The blowing or expanding agents may reduce theamount of adhesive needed and decrease the cost of production. In someembodiments, the application of heat or light may be delayed untilapplication of the drape 108 to the epidermis 116 so that the contactarea with the epidermis 116 may increase as the bonding adhesive 126 andthe sealing adhesive 144 warm by contact with the epidermis 116. Theapplication of light or heat following application of the drape 108 tothe epidermis 116 can provide a better seal for some embodiments of thedrape 108 to the epidermis 116.

A drape having a coated mesh may provide a lower cost solution thatmakes more efficient use of a sealing adhesive. The increase inefficiency of the use of a sealing adhesive may be accomplished withoutthe complication of adding extruders and pattern coaters that may berequired for pattern printing of adhesives. A drape having a coated meshmay have a higher MVTR than other drapes as the inclusion of meshapertures can permit greater passage of moisture without interferingwith sealing.

Although certain features and their advantages have been disclosed inthe context of certain illustrative, non-limiting embodiments, it shouldbe understood that various changes, substitutions, permutations, andalterations can be made without departing from the scope of the appendedclaims. It will be appreciated that features that may be described inconnection to one embodiment may also be applicable to otherembodiments. It will also be understood that the benefits and advantagesdescribed above may relate to one embodiment or may relate to severalembodiments. It will further be understood that reference to “an” itemrefers to one or more of those items.

The steps of the methods described herein may be carried out in asuitable order, or simultaneously where appropriate.

Where appropriate, aspects of the embodiments described above may becombined with aspects of the other embodiments described to form furtherexamples having comparable or different properties and addressing thesame or different problems.

It will be understood that the embodiments described herein are given byway of example only and that various modifications may be made by thoseskilled in the art. The above specification, examples and data provide acomplete description of the structure and use of exemplary embodiments.Although various embodiments have been described above with a certaindegree of particularity, or with reference to one or more individualillustrations, those skilled in the art could make numerous alterationsto the example embodiments without departing from the scope of theclaims.

1.-34. (canceled)
 35. A method for manufacturing a drape for anegative-pressure system, the method comprising: providing a film layer;coupling a layer of a bonding adhesive to the film layer; forming amesh; coating the mesh with a sealing adhesive; forming one or morebonding apertures in the mesh; and coupling the mesh to the layer of thebonding adhesive.
 36. The method of claim 35, wherein the bondingapertures are formed in the mesh before coating the mesh.
 37. The methodof claim 35, wherein forming the mesh comprises weaving a plurality offibers to form the mesh.
 38. The method of claim 35, wherein forming themesh comprises knitting a plurality of fibers to form the mesh.
 39. Themethod of claim 35, wherein forming the mesh comprises extruding aplurality of fibers to form the mesh.
 40. The method of claim 39,wherein extruding the plurality of fibers to form the mesh furthercomprises extruding the fibers so that the fibers intersect with aprominence less than about 1 millimeter.
 41. The method of claim 35,wherein the mesh comprises a plurality of fibers and a diameter of eachfiber is less than about 1 millimeter.
 42. The method of claim 35,wherein the mesh comprises a plurality of fibers and each fibercomprises a monofilament.
 43. The method of claim 35, wherein the meshcomprises a plurality of fibers and each fiber comprises a plurality oftwisted monofilaments.
 44. The method of claim 35, wherein the meshcomprises a plurality of fibers and each fiber comprises a staple fiber.45. The method of claim 35, wherein forming the mesh comprises formingthe mesh from a plurality of fibers having intersections and compressingthe mesh to reduce a prominence at each intersection of the fibers. 46.The method of claim 35, wherein forming the mesh comprises forming themesh from a plurality of fibers having intersections and calendaring themesh to reduce a prominence at each intersection of the fibers.
 47. Themethod of claim 35, wherein forming the mesh comprises forming the meshto have a plurality of mesh apertures each having an effective diameterbetween about 0.5 millimeters and about 4 millimeters.
 48. The method ofclaim 35, wherein coating the mesh comprises applying a coating weightof the sealing adhesive between about 100 grams per square meter andabout 500 grams per square meter.
 49. The method of claim 35, whereinforming the bonding apertures in the mesh comprises forming each bondingaperture with an effective diameter between about 5 millimeters andabout 15 millimeters.
 50. (canceled)